Supplier Management

Supplier Management

Companies that supply a manufacturer with components are a critical part of your manufacturing process.  If you manufacture medical devices, there are numerous requirements for control of these suppliers.  The FDA essentially considers a supplier an extension of the manufacturer, meaning that the service/material supplied must meet pre-established specifications.  According to 21 CFR 820, “Each…

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Management Representative

The FDA has a requirement, in 21 CFR 820.20, for a Management Representative.  This individual “irrespective of other responsibilities, shall have established authority over and responsibility for:  Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and Reporting on the performance of the quality system to management with…

Alert Lamp

Keys: Regular Alarm Checks & Preventive Maintenance

An extension of on-going support for your Continuous Monitoring (CM) system is to complete regular alarm checks and perform preventive maintenance. These two activities are vital to ensuring the integrity, quality and reliability of the system. Regular Alarm Checks Regularly scheduled alarm checks should be completed for: (1) all monitored parameters (temperature, humidity, differential pressure,…

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Environmental Monitoring

Environmental Monitoring (EM) is a basic requirement throughout numerous industries; food, cosmetics, drugs and medical devices.  It is intended to measure the cleanliness of an area, therefore verifying the biological safety of products being manufactured.  The depth of your EM program will be determined by the industry you’re in, whether or not you claim your…

CDC

Solutions for Maintaining Compliance with the New CDC Vaccine Requirements

Vaccines are critical tools in maintaining the health of our communities. The logistics of delivering vaccines and verifying that they consistently maintain their recommended temperature has always been a difficult task. At times, vaccines were found being stored outside of the manufacturer’s recommended range. Prolonged temperature excursions can result in the vaccines becoming ineffective. In…

Detour

Deviation

A deviation is described as a departure from an approved procedure or specification.  It represents a failure to meet requirements in the manufacture of product, in-process specifications or production requirements.  There is a difference between a planned or unplanned deviation.  Planned deviations have been approved before execution, whereas unplanned deviations (also called incidents) are technically…

Quality Control

GMP Failure Investigations

Investigations (also known as GMP Failure Investigations) are a requirement of 21 CFR 820.  It is expected that medical device manufacturers immediately conduct an investigation on all non-conforming or out-of-specification (OOS) products.  There are three phases to an effective investigation process: Phase 1: As soon as a non-conformance happens, the individual performing the task should…